SOUTH SAN FRANCISCO, Calif., Jan. 06, 2016 (GLOBE NEWSWIRE) -- OXiGENE, Inc. (Nasdaq:OXGN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to CA4P for the treatment of neuroendocrine tumors. The designation provides for seven years of marketing exclusivity following product approval. CA4P has previously received orphan drug designation from the FDA for the treatment of ovarian cancer.
“I am pleased that the FDA has provided the orphan designation to CA4P for neuroendocrine tumors,” stated William D. Schwieterman, M.D., President and Chief Executive Officer of OXiGENE. “Their grant of this designation is timely, as we have recently completed enrollment in our phase 2a clinical trial of CA4P in both gastrointestinal and pancreatic neuroendocrine tumors. We expect final data from this trial to be available later in 2016.”
Orphan designation can be granted by the FDA to product candidates that are intended to treat rare diseases that generally affect fewer than 200,000 people in the United States.
OXiGENE is a clinical-stage biopharmaceutical company developing vascular disrupting agents to treat cancer. VDAs selectively disrupt abnormal blood vessels that sustain tumors. The company's investigational drugs include CA4P (fosbretabulin), which is in development as a treatment for solid tumors, and OXi4503, which is in development for acute myeloid leukemia (AML). OXiGENE is dedicated to leveraging its intellectual property and therapeutic development expertise to bring life-extending and life-enhancing medicines to patients.
Safe Harbor Statement
This news release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Any or all of the forward-looking statements in this press release, which include the timing of advancement, outcomes, data and regulatory guidance relative to our clinical programs and achievement of our business and financing objectives may turn out to be wrong. Forward-looking statements can be affected by inaccurate assumptions OXiGENE might make or by known or unknown risks and uncertainties, including, but not limited to, the inherent risks of drug development, manufacturing and regulatory review, and the availability of additional financing to pursue and continue development of our programs. Additional information concerning factors that could cause actual results to materially differ from those in the forward-looking statements is contained in OXiGENE's reports to the Securities and Exchange Commission, including OXiGENE's reports on Form 10-K, 10-Q and 8-K. However, OXiGENE undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise. Please refer to our Annual Report on Form 10-K for the fiscal year ended December 31, 2014.
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